FDA

FDA acts to approve a new cholesterol lowering medicine called evolocumab (Repatha)

king The FDA approved evolocumab (Repatha)

August 27, 2015

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kingThe FDA approved evolocumab (Repatha)

August 27, 2015

The FDA approved a new cholesterol lowering medicine called Repatha for people who are not able to get their low-density lipoprotein (LDL) under control with diet and currently available medicines in the statin (HMGCoA reductase inhibitors) family. This follows the European Medicines Agency (EMA) approval of Repatha as the first-in-class PCSK9 inhibitor treatment May 22, 2015. The FDA previously approved a PCSK9 inhibitor called alirocumab (Praluent) for heterozygous familial hypercholesterolemia.

Repatha belongs to this new family (class) of medicines known as PCSK9 inhibitors. The medicine is actually a monoclonal antibody that inhibits PCSK9 and that inhibition leads to lower cholesterol. It is approved “for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.”

Repatha is approved (indicated for):

1)      Use in addition to diet and maximally-tolerated therapy with statin type (such as Lipitor-atorvastatin or Crestor-rosuvastatin) therapy in adults with heterozygous familial hypercholesterolemia  (HeFH) or

2)      Use in homozygous familial hypercholesterolemia (HoFH) or

3)      Use in clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

More information on the uses and terms in this release is available at:

Statin therapy: http://nlm.nih.gov/medlineplus/statins.html

Hypercholesterolemia: http://ghr.nlm.nih.gov/condition/hypercholesterolemia

Atherosclerotic cardiovascular disease: http://www.nhlbi.nih.gov/health/health-topics/topics/atherosclerosis/

A long-term study called FOURIER is currently underway. Fourier stands for Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk. The purpose of this study is to see if evolocumab (Repatha) is well-tolerated and decreases the risk of cardiovascular death, heart attack (myocardial infarction), hospitalization for unstable angina, stroke or coronary revascularization in people (subjects) with clinically evident cardiovascular disease. Visit www.clinicaltrials.gov and search NCT01764633 for more information.

Every medicine has a profile of benefits and risks as you've seen in the Essential Guide To Prescription Drugs. Most common side effects of Repatha include inflammation of the nasopharynx (nasopharyngitis), upper respiratory tract infection, flu, back pain, and reactions such as redness, pain, or bruising where the shot (injection) is given. There have been allergic reactions reported (such as rash and hives). People should stop taking Repatha and get medical help if they start to have these symptoms. The FDA press release is at www.FDA.gov.

FDA announces easier road and forms for experimental (investigational) medicines

 

The FDA IS listening

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The FDA IS listening

last resort Dr. Peter Lurie from the FDA announced a large step to help people looking to investigational medicines to treat serious diseases and conditions. The FDA listened well to the vulnerable patients and to physicians trying to navigate what was a complicated course to treatment.

The new draft document is called the Individual Patient expanded Access Applications: Form FDA 3926. This is complicated in the name alone. When the process is finalized, the form will immensely simplify and accelerate the process that your doctor will have to use to get an experimental (in FDA lingo-investigational) drug or biological treatment while it is still being tested to establish safety and efficacy. As usual, I will detail the true breakthroughs in medicines and those with particular interest in The Essential Guide to Prescription Drugs.

The form is still detailed, but FDA estimates hold that a doctor will need 45 minutes versus 100 HOURS to fill in the information. Nice move from the FDA at a time when physicians and patient just want a better way to attack disease. blogs.fda.gov/fdavoice/index.php/2015/02/a-big-step-to-help-the-patients-most-in-need/

Is the FDA keeping medical devices safe?

 

Is the FDA keeping medical devices safe?

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Is the FDA keeping medical devices safe?

A new program appears to be aimed at further accomplishing exactly that. The name is MDSAP (Medical Device Single Audit Program) It could be a milestone in that people who make medical equipment and  want to sell their products in Australia, Brazil, Canada, the US and Japan. The concept seeks to have a single audit or inspection to ensure that the medical device regulatory requirements are met.

Reviews (audits) will be conducted by third party vendors and medical device regulators in the countries will be able to use these inspection reports to make their regulatory decisions. It looks like the program would standardize the information the regulators get and will reduce the need to perform routine inspections. The people who make the medical equipment may benefit by cutting down on the number of regulatory audits they have to host, letting them keep their plants active making the products they want to sell.

Time will tell if this new MDSAP will be a win win for everyone, but it appears to be just the ticket for a more standard review and fewer inspections, yet better products.  

Could a PCSK9 inhibitor treat YOUR cholesterol soon?

 

Climbing the mountain toward EU

and US approval is a new cholesterol treatment called evolocumab (no name yet other than AMG-145). Have you heard of the PCSK9 inhibitor family? Probably not, but it’s worth a closer look and the Amgen molecule may be the first out of the box.

New test for Alzheimer's may give us an early wake up call

women The FDA approved a new agent for detecting Alzheimer's early. The PET scan agent is called florbetapir (Amyvid) and it just may be a new ticket to early detection and treatment !!!

Generic Lexapro (escitalopram) approved by the FDA

black haired woman The FDA approved a generic version of the widely prescribed depression and anxiety medicine, Lexapro (escitalopram).

Approval Date: 
Wed, 03/14/2012
Company: 
Teva/Vax

Sientra silicone breast implant approved by FDA conditional on after-approval studies for 10 years

woman by fireplace Silicone breast implants are used in women requiring breast tissue reconstruction at any age and also for increasing breast size (augmentation) for women over 22. 

This website is not intended as medical advice, and you should consult your doctor before changing or adding any medicines or vitamins to those you may now be taking and about applying any strategies BEFORE you adopt any approach in this report. While diligent care has been taken to ensure the accuracy of the information provided during the preparation of this edition, no claim is made that all known actions, uses or side effects, strategies for cost containment, targets or cholesterol pathways are included in this report. The accuracy and currentness of information are ever subject to change relative to new guidelines, new information derived from drug research, development and general usage.